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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 261 drug applications between 9 September 2022 and 15 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 35 drug names.

2022/09/09 – 2022/09/15

Period
2022/09/09 to 2022/09/15, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
261
Drugs with new generic filings (by drug name, de-duplicated)
35
Accepted this week, now under review
0

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

261filings, 44 of them generic

By application type

Application typeFilings
Supplement155
Generic44
New drug28
Import20
Import re-registration8
Unspecified6

By drug type

Drug typeFilings
Chemical drug189
Therapeutic biologic39
TCM31
Prophylactic biologic2

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

35 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cefotiam Hydrochloride For Injection310
2Nintedanib Esilate Soft Capsules216
3Peramivir Injection217
4Vardenafil Hydrochloride Tablets214
5Minoxidil Liniment2152
6Calcium Gluconate in Sodium Chloride Injection215
7Potassium Aspartate Injection213
8Aripiprazole Oral Solution214
9Morinidazole and Sodium Chloride Injection119
10地氯雷他定口服溶液 · No verified English name1126

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

152 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Jin Xing Industrial Co., Ltd. romanized1060
2Shandong Kong Sheng Tang Pharmaceutical Co., Ltd. romanized660
3Baxalta US Inc.610
4Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized610
5Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized550
6AstraZeneca AB530
7Boehringer Ingelheim International GmbH510
8Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized510
9Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized440
10Jiangxi Ke Rui Pharma Co., Ltd. romanized440

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

68 this week

AcceptedDrugApplicants
2022/09/15Import · Class 2.2 奥妥珠单抗注射液 · No verified English nameJXSL2200165 F.Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/09/15Import · Class 1 LY3819469注射液 · No verified English nameJXHL2200285 Eli Lilly and Company
2022/09/15Generic · Class 3 Terbutaline Sulfate InjectionCYHS2201528 Jilin Si Zhang Pharmaceutical Co., Ltd. romanized
2022/09/15Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2201526 Shanghai Ling Tong Pharmaceuticals Technology Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized
2022/09/15Generic · Class 3 Potassium Aspartate InjectionCYHS2201524 Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized
2022/09/15Generic · Class 3 Potassium Aspartate InjectionCYHS2201521 Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized
2022/09/15Generic · Class 3 Famotidine InjectionCYHS2201520 Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2022/09/15Generic · Class 3 Clonazepam InjectionCYHL2200077 Jiangsu En Hua Pharma Co., Ltd. romanized
2022/09/15New drug · Class 2.3 芪参益气滴丸 · No verified English nameCXZL2200042 Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized
2022/09/15New drug · Class 1 注射用MBS303 · No verified English nameCXSL2200461 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized
2022/09/15New drug · Class 1 GR1802注射液 · No verified English nameCXSL2200460 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized; Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2022/09/15New drug · Class 1 APG-115胶囊 · No verified English nameCXHL2200677 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2022/09/15New drug · Class 1 APG-115胶囊 · No verified English nameCXHL2200676 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2022/09/15New drug · Class 1 SC0062胶囊 · No verified English nameCXHL2200675 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2022/09/15New drug · Class 1 SC0062胶囊 · No verified English nameCXHL2200674 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2022/09/15New drug · Class 2.4 Regadenoson InjectionCXHL2200673 Nanjing Rui Ke Wei Biopharmaceuticals Co., Ltd. romanized
2022/09/14Import · Class 1 VAY736注射液 · No verified English nameJXSL2200164 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/09/14Generic · Class 3 Magnesium Sulfate InjectionCYHS2201519 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2022/09/14Generic · Class 3 Milnacipran Hydrochloride TabletsCYHS2201514 Hebei Long Hai Pharma Co., Ltd. romanized
2022/09/14Generic · Class 3 Minoxidil LinimentCYHS2201512 Ningbo Mei Shu Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/09/14Generic · Class 3 Minoxidil LinimentCYHS2201511 Ningbo Mei Shu Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/09/14New drug · Class 2.2 人干扰素α2b喷雾剂 · No verified English nameCXSL2200459 Beijing Kai Yin Technology Co., Ltd. romanized
2022/09/14New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSL2200458 Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized
2022/09/14New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2200457 Zhejiang Quan Sheng Bio Technology Co., Ltd. romanized
2022/09/13Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2201510 Jiangxi Shimei Pharmaceutical Co., Ltd
2022/09/13Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2201509 Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2022/09/13Generic · Class 3 Hydrotalcite SuspensionCYHS2201508 Hangzhou Min Sheng Health Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/09/13New drug · Class 1 SYH2045片 · No verified English nameCXHL2200672 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2022/09/13New drug · Class 1 SYH2045片 · No verified English nameCXHL2200671 Shanghai Yi Shi Pharmaceuticals Technology Co., Ltd. romanized
2022/09/10Import · Class 1 利特昔替尼胶囊 · No verified English nameJXHS2200081 Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd.

38 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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